Quillivant XR

(methylphenidate hydrochloride)

Quillivant XR (methylphenidate hydrochloride); CII

Summary

Quillivant XR is a long-acting methylphenidate supplied as a banana-flavoured powder the pharmacist reconstitutes into an extended-release oral suspension, dosed from age 6 with no upper limit. Drug is ion-bound to resin held in suspension, giving a full school-day profile as a liquid. It is the only long-acting methylphenidate dosed by the millilitre. Schedule II; brand only.

Forms & Strengths

• Extended-release oral suspension (banana, contains sucrose; reconstituted from powder): 25 mg/5 mL, that is 5 mg/mL

Dosing

• Age: >= 6y; no upper limit
• Onset: ~ 45 minutes
• Duration: up to 12 hours
• Release Profile: 20% IR / 80% ER via drug ion-bound to suspended resin
• Initial Dose: 20 mg, which is 4 mL, once daily in the morning
• Titration: 10 - 20 mg every 7 days
• Max Dose: 60 mg/day, which is 12 mL
• Considerations: Shake vigorously at least 10 seconds before every dose or the dose drawn will be wrong. The reconstituted suspension is stable 4 months at room temperature.

Pharmacology

• Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
• Delivery / Release: 20% IR / 80% ER. Drug is complexed to resin particles that settle, which is why the bottle must be shaken before every dose. Median Tmax about 4 hours.
• Metabolism: De-esterified to ritalinic acid, inactive. No CYP pathway. Terminal half-life ~5.2 h in children, ~5.6 h in adults; ~90% recovered in urine.
• Class Positioning: The only full-day methylphenidate that is a true liquid with a continuous dose. Same 12 hours as Cotempla XR-ODT but with millilitre granularity; QuilliChew ER covers 8 hours.

Indications

• ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older

Off-Label Uses

• Narcolepsy (ICD-10: G47.411, G47.419): IR methylphenidate carries this indication, Quillivant XR does not. Limited data.
• ADHD in children under 6 years (ICD-10: F90.x): the label records evidence against. Higher exposure than older children at the same dose, and more adverse reactions including weight loss. (AHRQ 2024)
• Weight-based or mg/kg dosing: the ladder is fixed at 20 mg for everyone 6 and above. Insufficient.
• Enteral feeding tube: not studied; a resin suspension is a plausible tube-blocking hazard. Insufficient.
• Adolescents and adults: the efficacy study enrolled 45 children aged 6 to 12. Limited data.

Contraindications & Warnings

• Boxed Warning: Abuse, misuse and addiction, with overdose and death; risk rises with dose and non-oral routes. Assess abuse risk before prescribing and reassess throughout treatment.
• Contraindicated:
  • Hypersensitivity to methylphenidate; angioedema and anaphylaxis reported
  • MAOI use, current or within 14 days: hypertensive crisis
• Use with caution:
  • Structural cardiac abnormality, cardiomyopathy, arrhythmia or coronary disease: avoid
  • Pre-existing hypertension: mean rises 2 to 4 mmHg and 3 to 6 bpm
  • Psychotic or bipolar disorder: exacerbation and treatment-emergent mania
  • Personal or family history of tics or Tourette's; tic ran 2% against 0% on placebo
  • Significant hyperopia or angle-closure risk: refer to ophthalmology
  • Substance use disorder in patient or household; a sweet liquid is the most accessible presentation here
• Screen before starting:
  • Cardiac history and exam, plus family history of sudden death; mandatory in section 2.1
  • Tics or Tourette's, personal and family, with clinical evaluation; also mandatory
  • Whether the caregiver can shake the bottle and draw an accurate volume daily
  • Mania risk factors; abuse and diversion risk in patient and household
  • Baseline height, weight, blood pressure and heart rate

Drug Interactions

• MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Contraindicated within 14 days.
• Antihypertensives: effectiveness reduced. Increase BP monitoring and adjust the antihypertensive.
• Halogenated anesthetics (sevoflurane, isoflurane, desflurane): intraoperative BP and HR surge. Hold on the day of surgery.
• Risperidone: EPS may increase when either dose changes in either direction. Monitor across any titration.
• Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, tramadol): serotonin syndrome in postmarketing reports only. Counsel on symptoms rather than avoiding.
• Alcohol: the label says avoid it; exposure rose about 20% at 20% alcohol, smaller than the bead and chewable products.
• Gastric pH modulators (H2-blockers, PPIs): not on this label, though the sibling resin product Cotempla XR-ODT restricts them. Uncharacterised here.

Administration

• Reconstitution is a pharmacist step: add the specified water volume, insert the adapter, shake 10 seconds, dispense in the original carton with the dispenser.
• Shake vigorously at least 10 seconds before every dose; an unshaken bottle runs weak early and strong late.
• Beyond-use date 4 months. Have the pharmacy date the bottle. Store at room temperature, not refrigerated.
• Once daily in the morning. Food does not delay it; a high-fat meal shortens Tmax by about an hour.
• Measure with the supplied dispenser, never a kitchen spoon; milligrams divided by five gives millilitres.
• Missed dose: give the next as scheduled; never double up or dose late in the day.
• Switching from another methylphenidate: re-titrate from 20 mg weekly, never mg-per-mg.
• Store locked; a palatable liquid is the easiest form for an unintended child to swallow.

Side Effects

• Common, this product (45 patients, 6 to 12 y): affect lability 9% vs 2%, excoriation 4% vs 0%, and insomnia, tic, decreased appetite, vomiting, rash each 2% vs 0%.
• Common, pooled methylphenidate: decreased appetite and weight, nausea, abdominal pain, insomnia, anxiety, irritability, dizziness, tremor, raised BP and heart rate.
• Serious:
  • Sudden death with structural cardiac disease: avoid the drug rather than monitor through it
  • New psychosis or mania, ~0.1% pooled, including with no psychiatric history: consider discontinuing
  • Priapism, sometimes surgical, typically after a dose increase and also during drug holidays
  • Peripheral vasculopathy and Raynaud's with digital ulceration: assess digits each visit
  • Growth suppression: about 2 cm and 2.7 kg less over 3 years
  • Acute angle closure glaucoma; new or worsening tics and Tourette's: discontinue if appropriate
  • Hypersensitivity including angioedema and anaphylaxis
  • Postmarketing: severe hepatocellular injury, serotonin syndrome, seizures, rhabdomyolysis, pancytopenia

Monitoring & Labs

• Shaking technique: at the first follow-up and any unexplained change in effect, have the caregiver show how they shake. Effect drifting across the month is the signature failure.
• Beyond-use date and dose volume: check the reconstitution date and the millilitres drawn at every refill and dose change. A misread dispenser is a silent halving or doubling.
• Affect lability: ask at every visit. The highest signal in this product's own trial, 9% against 2%.
• Cardiovascular: BP and HR at baseline, at each dose change, and every 6 months.
• Growth: height, weight and BMI at baseline and every 6 months. Crossing two percentile lines is a labeled trigger to interrupt.
• Appetite, sleep, psychiatric and tics: at every visit and after each dose increase; inspect fingers and toes for colour change or ulceration.
• Abuse and diversion: reconcile volume remaining against days elapsed at each refill and check the PDMP. A boxed-warning obligation.
• Laboratory: none required. Check LFTs only for jaundice, dark urine or unexplained fatigue. Discontinue if no improvement after one month of appropriate adjustment.

Discontinuation & Taper

• Can be stopped abruptly at therapeutic doses; the label gives no taper schedule.
• Withdrawal after prolonged use: dysphoria, fatigue, vivid dreams, sleep change, increased appetite.
• Down-titration is smoother than on any solid: 1 mL, that is 5 mg, steps.
• Reduce or discontinue for paradoxical worsening or adverse reactions.
• Drug holidays are reasonable where growth limits treatment, but a long one outlasts the bottle.
• Priapism has been reported during drug holidays and on discontinuation.

Pregnancy & Lactation

• Pregnancy: human data are insufficient to inform a drug-associated risk. Stimulant vasoconstriction may reduce placental perfusion. Background risk 2% to 4% and 15% to 20%. Weigh against untreated maternal ADHD.
• Lactation: infant dose 0.16% to 0.7% of the maternal weight-adjusted dose; undetectable in infant plasma in every reported case. Monitor for agitation, poor feeding and reduced weight gain. Not a reason to stop breastfeeding. (LactMed 2025)
• Lactation, milk supply: prolactin falls; large doses may interfere before supply is established. (LactMed 2025)
• Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388, womensmentalhealth.org.

Counseling Points

• Counsel the family on:

  • Shaking hard for a full 10 seconds before every dose. Count it out loud with them once; a poorly shaken bottle runs weak then strong across the month.
  • The 4-month limit from the reconstitution date, room-temperature storage, and using only the supplied dispenser: 1 mL is 5 mg.
  • The flavour being banana, so a child who has refused banana medicines will refuse this.
  • Emotional swings being a recognised effect of this product, manageable by dose. Move the largest meal to breakfast and the evening.
  • Locked storage; a toddler can drink a large amount of a sweet liquid quickly.

• Advise them to call for:

  • Chest pain, fainting, or a racing heart that does not settle.
  • New hallucinations, or suspicious or fearful thinking.
  • Numbness, coldness or colour change in fingers or toes.
  • A new or markedly worse tic, or a new vocal tic.
  • Weight loss, clothes fitting more loosely, or a marked change in emotional control.
  • A painful erection lasting more than a few hours.
  • Yellowing of the eyes or skin, dark urine, or new eye pain with halos around lights.
  • Any amount swallowed by a child it was not prescribed for.

References

1. DailyMed. Quillivant XR (methylphenidate hydrochloride) for extended-release oral suspension prescribing information. NextWave Pharmaceuticals Inc. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c2dc2109-44a6-4797-b04e-18761dd9d45a
2. LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
3. FDA. openFDA National Drug Code Directory, methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22
4. AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
5. American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
6. DEA. Drug scheduling. Methylphenidate is a Schedule II controlled substance. https://www.dea.gov/drug-information/drug-scheduling